Safety of Rituximab in PSA and psoriasis by determining incidence of treatment emergent AE's including infections, infusion reactions and disease progression. [ Time Frame: followed out for one year from last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The exploration of efficacy of rituximab in PsA will be determined by using the week 24 ACR 20 measurement as modified for PsA using 68/66 tender/swollen joint count. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment:

6

Study Start Date:

December 2006

Study Completion Date:

March 2010

Primary Completion Date:

January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: Rituximab

1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15). The first infusion of rituximab should be administered IV at an initial rate of 50 mg/hr. If a hypersensitivity or infusion related reaction does not occur, escalate the infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.

Other Name: Rituxan

Detailed Description:

The purpose of this study is to evaluate safety and efficacy of rituximab, with and without methotrexate, in joints, enthesium and skin in psoriatic arthritis patients with inadequate response to methotrexate who have either not tried anti-TNF therapy or have had inadequate or failed response to anti-TNF therapy. To explore biologic mechanism of action via histological and immunohistochemical evaluation of pre and post treatment biopsies of psoriatic plaques.

Eligibility

Ages Eligible for Study:

18 Years to 80 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Active disease of at least 6 months duration.

Receiving treatment on an outpatient basis.

The patient will have at least one evaluable skin plaque, 2 cm in diameter, that can be followed with a target lesion score (scalp and groin lesions cannot be used).

Subjects will have greater than or equal to 3 tender (out of 68 joints) and 3 swollen (out of 66) joints at screening and baseline.

Exclusion Criteria:

History of malignancy other than resolved squamous or basal cell or cervical carcinoma

Presence of a significant medical illness that, in the opinion of the investigator, would potentially compromise the subject's ability to participate in the trial

Presence of another rheumatic or skin disease that, in the opinion of the investigator, could confound the ability to discern response

History or presence of HIV

History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies

History of recurrent significant infection or history of recurrent bacterial infections

Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.

History of psychiatric disorder that, in the judgment of the investigator, would make the patient inappropriate for entry into this trial or would lead to poor compliance.

Concurrent treatment with any DMARD (except for MTX), any anti-TNF alpha therapy or other biologic therapy. Topical medications to treat psoriasis are limited to class VI and VII low potency steroids to the palms, soles of the feet, axilla and groin only.

Concurrent treatment with any DMARD (except for MTX), any anti-TNF alpha therapy or other biologic therapy. Topical medications to treat psoriasis are limited to class VI and VII low potency steroids to the palms, soles of the feet, axilla and groin only.

Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer).

Subjects should not take analgesics within 12 hours prior to joint assessments

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509678